Senior Regulatory Affairs Specialist

2 weeks ago

Ottawa, Ontario, Canada Abbott Laboratories Full time

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

  • Career development with an international company where you can grow the career you dream of.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Ottawa, Ontario location in the Point of Care, Diagnostics division. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics and toxicology. As the Senior Specialist Regulatory Affairs, Advertising & Promotions you will be responsible for reviewing medical education and commercial advertising and promotional materials for product, disease state, and training/education programs.

What You'll Do

  • Responsible for timely and accurate review of all advertising and promotional materials.
  • Ensure that reviewed promotional materials are (i) accurate, truthful, and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures.
  • Evaluate FDA guidance documents, policies and the overall regulatory environment and be able to assess and communicate potential risk and impact.
  • Ensure compliance with FDA advertising and promotional regulations and guidelines for select product, disease state, and all medical education materials.
  • Ensure communications and promotional claims are following the terms of approved global product registrations, applicable laws, internal policies and external regulations.
  • Evaluate global regulations regarding advertising and promotion; ensure compliance.
  • Continually assesses advertising and promotion-related processes and procedures to enhance efficiencies and compliance and recommend/implement policy and/or process changes as needed.
  • Work independently and recognize when issues need to be elevated to management.
  • Participate in regulatory intelligence gathering activities and maintain knowledge of US, Health Canada, EU and ROW regulatory requirements.
  • Develop and update training resources on materials review process.
  • Serve as primary point of contact and RA representative for all matters related to advertising and promotion of products.
  • Collaborate with marketing operations on prioritization for routine approvals as well as during major events and campaign launches.
  • Review and approve non-promotional items such internal training documents and internal communications.
  • Provide regulatory technical support and supplement leadership and guidance to the marketing team during the development, review and approval of product advertising materials.
  • Mentor other regulatory professionals.

Required Qualifications

  • Bachelor's degree in a technical discipline (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, or medical field).
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.).
  • 5 years' work experience with at least 3 years of experience in regulatory.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.

Preferred

  • Experience with IVD's.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

  • Senior Regulatory Affairs Specialist

    2 days ago

    Ottawa, Ontario, Canada Abbott Laboratories Full time

    Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Abbott Laboratories. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines related to advertising and promotional materials.Key ResponsibilitiesReview and approve...

  • Senior Regulatory Affairs Specialist

    2 days ago

    Ottawa, Ontario, Canada Abbott Laboratories Full time

    Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Abbott Laboratories. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines related to advertising and promotional materials.Key ResponsibilitiesReview and approve...

  • Senior Executive

    5 days ago

    Ottawa, Ontario, Canada Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Senior Executive - Regulatory AffairsCompany: Sun Pharmaceutical Industries LtdLocation: R&DJob Summary:We are seeking a highly skilled Senior Executive to join our Regulatory Affairs team. The successful candidate will be responsible for reviewing data and documents related to product registrations for various health authorities.Key...

  • Senior Executive

    3 days ago

    Ottawa, Ontario, Canada Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Senior Executive - Regulatory AffairsCompany: Sun Pharmaceutical Industries LtdLocation: R&DJob Summary:We are seeking a highly skilled Senior Executive to join our Regulatory Affairs team. The successful candidate will be responsible for reviewing data and documents related to product registrations for various health authorities.Key...

  • Regulatory Affairs and Compliance Specialist

    3 weeks ago

    Ottawa, Ontario, Canada NAV CANADA Full time $125,327 - $145,528

    Position Title: Regulatory Affairs and Compliance Specialist Job Type: Full-time Language Requirements: English / Anglais Flexible Work Agreement Type: Remote / Travail à distance The Regulatory Affairs and Compliance Specialist serves as a key resource in establishing NAV CANADA's regulatory stance to support both domestic and international operational...

  • International Regulatory Affairs Specialist

    3 weeks ago

    Ottawa, Ontario, Canada NAV CANADA Full time

    Job Summary The International Regulatory Affairs Specialist plays a crucial role in ensuring compliance with global regulations and standards. This position is integral to the operational support team, focusing on the strategic planning and execution of regulatory initiatives. Key Responsibilities Develop and implement regulatory strategies that align...

  • Regulatory Affairs Manager

    3 weeks ago

    Ottawa, Ontario, Canada Farm Boy Full time

    Company Overview At Farm Boy, we are dedicated to delivering a vibrant and enjoyable shopping experience for everyone. Our commitment to quality and freshness drives us to create a unique food shopping environment for both our team members and customers. As we expand across Ontario, we are eager to find individuals who share our enthusiasm for providing...

  • Regulatory Affairs Manager

    3 weeks ago

    Ottawa, Ontario, Canada Farm Boy Full time

    Company Overview At Farm Boy, we are dedicated to providing an enjoyable and fresh shopping experience for everyone. Our commitment to excellence drives us to create a unique environment for both our team members and customers. As we expand across Ontario, we are eager to welcome individuals who share our enthusiasm for delivering top-notch fresh food...

  • Regulatory Affairs Manager

    3 weeks ago

    Ottawa, Ontario, Canada Farm Boy Full time

    Company Overview At Farm Boy, we are dedicated to providing an enjoyable and fresh shopping experience for all. Our commitment extends to both our team members and customers, as we strive to deliver a unique fresh food shopping environment. As we expand within Ontario, we are eager to bring on new team members who share our enthusiasm for delivering the...

  • Regulatory Affairs Specialist

    3 days ago

    Ottawa, Ontario, Canada beBee Professionals Full time

    Job SummarybeBee Professionals is seeking an experienced Aviation Compliance Specialist to fill a key role in our organization. The successful candidate will be responsible for ensuring that all aviation operations are conducted in accordance with applicable regulations and standards.Key ResponsibilitiesMonitor and evaluate aviation operations to ensure...

  • Regulatory Affairs Specialist

    5 days ago

    Ottawa, Ontario, Canada beBee Professionals Full time

    Job SummarybeBee Professionals is seeking an experienced Aviation Compliance Specialist to fill a key role in our organization. The successful candidate will be responsible for ensuring that all aviation operations are conducted in accordance with applicable regulations and standards.Key ResponsibilitiesMonitor and evaluate aviation operations to ensure...

  • Senior Change Management Specialist

    3 days ago

    Ottawa, Ontario, Canada S.i. Systèmes Full time

    Job Title: Senior Change Management SpecialistJob Summary:S.i. Systèmes is seeking a highly skilled Senior Change Management Specialist to join our team. As a key member of our organization, you will be responsible for implementing a service delivery and performance metric framework to support a regulatory project.About the Role:The current team structure...

  • Senior Change Management Specialist

    3 days ago

    Ottawa, Ontario, Canada S.i. Systèmes Full time

    Job Title: Senior Change Management SpecialistJob Summary:S.i. Systèmes is seeking a highly skilled Senior Change Management Specialist to join our team. As a key member of our organization, you will be responsible for implementing a service delivery and performance metric framework to support a regulatory project.About the Role:The current team structure...

  • Regulatory Policy Analyst

    3 weeks ago

    Ottawa, Ontario, Canada Collage HR Full time

    Position Overview:As a key member of the team, the Regulatory Policy Analyst will engage in critical research and analysis within the regulatory affairs sector. This role is essential for understanding and influencing the landscape of nuclear policy in Canada.About the Organization:Collage HR is dedicated to fostering a thriving nuclear industry that serves...

  • Regulatory Affairs Expert

    5 days ago

    Ottawa, Ontario, Canada Farm Boy Full time

    About the RoleWe are seeking a highly skilled Food Safety Specialist to join our team at Farm Boy. As a key member of our quality assurance team, you will play a critical role in ensuring the highest standards of food safety and quality across our operations.Key ResponsibilitiesRespond to customer inquiries and complaints related to regulatory questions in a...

  • Regulatory Affairs Expert

    3 days ago

    Ottawa, Ontario, Canada Farm Boy Full time

    About the RoleWe are seeking a highly skilled Food Safety Specialist to join our team at Farm Boy. As a key member of our quality assurance team, you will play a critical role in ensuring the highest standards of food safety and quality across our operations.Key ResponsibilitiesRespond to customer inquiries and complaints related to regulatory questions in a...

  • Senior Federal Affairs Consultant

    3 weeks ago

    Ottawa, Ontario, Canada Canadian Association of Petroleum Producers Full time

    About UsThe Canadian Association of Petroleum Producers (CAPP) is a non-partisan, research-driven industry organization that advocates for our member companies, both large and small, engaged in the exploration, development, and production of oil and natural gas across Canada. Our associate members offer a diverse array of services that support the upstream...

  • Regulatory Compliance Specialist

    3 weeks ago

    Ottawa, Ontario, Canada Alterna Savings Full time

    Position Overview The Regulatory Compliance Specialist will play a crucial role in supporting the framework for Regulatory Compliance Management. This position is recognized as a subject matter expert in regulatory controls. Key responsibilities include evaluating and analyzing risks associated with regulations in accordance with compliance policies and...

  • International Regulatory Affairs Coordinator

    3 weeks ago

    Ottawa, Ontario, Canada NAV CANADA Full time

    Position Overview What NAV CANADA provides: Engaging and collaborative work atmosphere Attractive salary and adaptable benefits Secure pension plan Opportunities for professional advancement Flexible working options A diverse and inclusive workforce Primary Responsibilities: Serve as a consultative and strategic link between State...

  • Senior Branch Oversight Specialist

    3 days ago

    Ottawa, Ontario, Canada Scotiabank Full time

    Job SummaryWe are seeking a highly skilled Senior Branch Oversight Specialist to join our Regulatory Affairs team in Canada. As a key member of our team, you will be responsible for ensuring the overall success of the Branch Oversight Team, executing individual goals, plans, and initiatives in support of our business strategies and objectives.Key...